BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSPEED VCT

    MDR report key: 2093951 · Received April 22, 2011

    Report

    Report Number
    2126677-2011-00085
    Event Type
    Other
    Date Received
    April 22, 2011
    Date of Event
    May 24, 2010
    Report Date
    April 21, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K061817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO SYSTEM MALFUNCTION WAS REPORTED OR DETERMINED TO EXIST AFTER TROUBLESHOOTING AND INVESTIGATION. MEASUREMENT AND EVALUATION OF THE SCAN PARAMETERS USED BY THE SITE FOR THESE EXAMINATIONS SHOWS THAT THE DOSE ADMINISTERED TO THE PATIENT (4.47 GY) WAS GREATER THAN THE RECOGNIZED THRESHOLD LEVEL FOR DETERMINISTIC EFFECTS SUCH AS SKIN REDDENING AND TEMPORARY HAIR LOSS. THE DOSE PRESCRIBED BY THE SITE WAS SIGNIFICANTLY GREATER THAN GE AND THE SITE'S DEFAULT PROTOCOLS. THE GE PROVIDED PROTOCOL FOR THIS SCAN TYPE RESULTS IN A PATIENT DOSE THAT IS SIGNIFICANTLY LOWER THAN INDUSTRY AND FDA RECOGNIZED THRESHOLD LEVELS FOR POSSIBLE DETERMINISTIC EFFECTS. THE SITE'S DEFAULT PROTOCOL FOR PERFUSION SCANNING WAS FOUND TO BE IN ACCORDANCE WITH GE REFERENCE PROTOCOL RECOMMENDATIONS FOR IMAGING AND DOSE. ACCORDING TO THE SITE, THE TECHNICIAN MANUALLY INCREASED THE MA ON THE EXAM IN ORDER TO ENHANCE THE IMAGE QUALITY ALTHOUGH IMAGES CAPTURED AT THE SITE WITH ORIGINAL UNALTERED DEFAULT PROTOCOLS WERE OF DIAGNOSTIC QUALITY. GE ANALYSIS OF THE ACTUAL SCAN PARAMETERS SHOW THAT A SIGNIFICANT INCREASE TO THE KV OUTSIDE OF DEFAULT SYSTEM PARAMETERS ALSO OCCURRED. THE SITE RETRAINED THEIR STAFF OF TECHNOLOGISTS NOT TO CHANGE THE DEFAULT PROTOCOLS. TECHNIQUES AND DOSE ARE INCORPORATED INTO THE SITE'S NEW TECHNOLOGIST TRAINING AND ANNUAL EVALUATIONS. THE OPERATORS ARE LICENSED, TRAINED, AND ARE UNDER SITE-SPECIFIC PROCEDURES CONCERNING PATIENT DOSE AND EXAM PRESCRIPTION. FACILITIES ARE RECOMMENDED TO MONITOR PATIENT DOSE AND TO PAY CLOSE ATTENTION TO ANY EXAM PRESCRIPTION THAT COULD APPROACH LEVELS AS DISCUSSED BY THE FDA AS THRESHOLDS FOR DETERMINISTIC EFFECTS. IN ACCORDANCE WITH (B)(4), THE SYSTEM IS DESIGNED TO CALL SPECIAL ATTENTION TO ALL PRESCRIPTIONS IN WHICH THE USER IS PRESCRIBING MORE THAN ONE SCAN AT A SINGLE LOCATION. THIS IS IN THE FORM OF A POP UP WARNING MESSAGE THAT REQUIRES USER ACKNOWLEDGEMENT TO CONTINUE. THE SCAN PARAMETERS ARE DISPLAYED FOR THE OPERATOR AND CONFIRMATION IS REQUIRED PRIOR TO STARTING THE SCAN. THIS CONFIRMATION IS DONE BY CLICKING A BUTTON ON THE SAME WINDOW AS THE SCAN PARAMETERS. ADDITIONALLY, PRODUCT LABELING SPECIFICALLY WARNS THE OPERATOR WITH THE FOLLOWING STATEMENT: "PROLONGED EXPOSURE TO X-RAY IN ONE SPOT MAY CAUSE REDDENING OR RADIATION BURNS. USER MUST BE AWARE OF THE TECHNIQUES USED AND EXPOSURE TIME TO INSURE SAFE OPERATION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A HIGH LEVEL OF DOSE EXCEEDING THE RECOGNIZED THRESHOLD LEVEL FOR DETERMINISTIC EFFECTS FROM A BRAIN PERFUSION SCAN. THE PATIENT WAS CONTACTED BY THE HOSPITAL, BUT DID NOT REPORT ANY SIGNS OF DETERMINISTIC EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSPEED VCT COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK GE MEDICAL SYSTEMS, LLC 5124069-5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other